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DIA/FDA Biostatistics Industry and Regulator Forum

This event is now offered in a new entirely virtual format.


Session 8: Current Issues in Adaptive Design and Evolving ICH E20 Guidance and Closing Remarks

Session Chair(s)

Erik  Pulkstenis, PhD

Erik Pulkstenis, PhD

  • Vice President, Data and Statistical Sciences
  • Abbvie, United States
Fairouz  Makhlouf, PhD

Fairouz Makhlouf, PhD

  • Deputy Director, Office of Biostatistics, Office of Translational Science, CDER
  • FDA, United States
Adaptive designs have received significant attention over the last 15 years in the literature, regulatory guidance, and clinical trial practice as their use has increased supporting both early/mid-stage trials as well as registrational trials. The potential advantages including ethical considerations, accelerated decision making and efficient resource utilization are well known as are associated challenges like type-1 error control, estimation, and vigilance required to maintain trial integrity in the context of mid-trial data analysis and decision making. Regulatory guidance has emerged from around the world and ICH harmonization is currently ongoing. In this session, we will hear from key members of the ICH E20 working group who will orient us to the process as well as discuss a variety of issues that require careful thought in the implementation of these trials.
Learning Objective : At the conclusion of this session, participants should be able to:
  • Explain the objectives of ICH E20 and the associated harmonization process
  • Describe some of the key issues related to adaptive designs

Speaker(s)

John  Zhong, PhD

ICH E20 Adaptive Design Guidance Development Process and Status Update

John Zhong, PhD

  • Vice President, Head of Biometrics
  • REGENXBIO, Inc., United States
John  Scott, PhD, MA

ICH E20 Adaptive Design Considerations and Current Issues

John Scott, PhD, MA

  • Director, Division of Biostatistics, OBPV, CBER
  • FDA, United States